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Glossary

International Committee for Harmonisation (ICH)

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The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration.

The purpose of ICH is to reduce or eliminate the need to duplicate the testing carried out during the research and development of new medicines by recommending ways to achieve greater harmonisation in the interpretation and application of technical guidelines and requirements for product registration. Harmonisation would lead to a more economical use of human, non-human animal and material resources, and the elimination of unnecessary delay in the global development and availability of new medicines while maintaining safeguards on quality, safety, and efficacy, and regulatory obligations to protect public health.

Other glossary definitions

I

Investigational New Drug (IND)

Administering an investigational drug to humans is subject to prior approval from regulatory authorities. Investigational…

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P

Pharmacovigilance System Master File (PSMF)

A Pharmacovigilance System Master File is a document describing the pharmacovigilance system used by the…

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